SQUIBB's AZACTAM ANTIBACTERIAL ACTIVITY IS "COMPARABLE OR SUPERIOR" TO CLAFORAN AND MOXAM, SQUIBB EXEC TELLS ANALYSTS; APPROVAL EXPECTED IN EARLY 1985
Executive Summary
Squibb's Azaetam (aztreonam) monobactam antibiotic "is comparable or superior" in antibacterial activity to Hoechst's Claforan (cefotaxime) and Lilly's Moxam (moxalactam), and "is unequivocally superior to gentamicin except for pseudomonas, acinetobacter and enterobacter," Squibb Exec VP Charles Sanders, MD, told a group of financial analysts April 3 at Goldman Sachs' Fifth Annual Healthcare Seminar in New York City. Sanders' comments were based on tests for aztreonam, cefotaxime, moxalactam and gentamicin antibacterial activity against a number of organisms including E. coli, K. pneumoniae, proteus mirabilis, salmonella, citrobacter, enterobacter, pseudomonas, acinetobacter and neisseria gonorrheae. Aztreonam's "lower activity against pseudomonas [v. gentamicin] is offset by greater safety," Sanders said, "permitting higher doses of aztreonam, and good synergy between aztreonam and aminoglycocides." He added that its "lack of activity against gram-positive and anaerobic organisms [such as staphylococcus aureus, streptococcus pneumoniae and bacteroides fragilis] is a very important attribute which contributes to the impressive safety profile" of the drug for treatment of gramnegative infections. Squibb expects FDA approval for Azactam by early 1985. An NDA for the drug was filed with the agency in December 1983. Sanders told the seminar group that "approval is pending in Italy" and "filings have been submitted in six other countries." In his prepared comments, Sanders pointed to the benefits narrow spectrum antibiotics such as aztreonam offer over broad spectrum treatments. "With the development of a so-called narrow spectrum antibiotic," he declared, "Squibb is leading the way in redefining the approach to antibiotic therapy . . . One could envision the combined use of a complementary broad spectrum antibiotic and Azactam in initial treatment for an infection of unknown cause and then omitting the broad spectrum antibiotic if the infection is found to be susceptible to Azactam. "This approach has the dual advantage of helping to maintain the normal bacterial flora, a necessary feature to preventing invasion of resistant bacteria or fungi, and minimizing the induction of bacterial resistance in bacteria normally found in the environment. By utilizing this approach we should prolong the effective life of our antibiotics and treat individual patients in a medically sound and cost effective manner." Squibb has identified four additional potential products stemming from its work with aztreonam. "The first and foremost of these," Sanders said, is an oral monobactam, SQ 28, 531, to complement injectable aztreonam. "It is moving along very well in man, and we expect it to move into Phase II in the latter part of this year." Squibb's oral monobactam "has a safety profile in animals that resembles aztreonam . . . is 10 to 100 times more potent against gram negative bacteria than the best oral cephalosporins and penicillins (including augmentin) . . . and we feel very confident that it will be competitively priced," Sanders said. Another Squibb goal is a second generation aztreonam. Although "it's a very difficult antibiotic to improve upon in some ways," Sanders explained, "we'd like to have it for greater pseudomonal activity." The Squibb R&D chief added: "We would like [also] to increase the spectrum so that it would be broad spectrum in a gram-positive sense. We feel that this is feasible. A number of leads have been identified, yet it is too early to say how effective this can be. Finally, we have developed a monobactam for animal health which is currently in development. I think the real question there is whether the economics will be worthwhile in terms of being competitive in that particular field."
You may also be interested in...
Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials
Shire Hopes To Sow Future Deals With $50M Venture Fund
Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth